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Details for article 9 of 21 found articles
| Title: |
Evaluation of statistical equivalence using limits of agreement and associated sample size calculation |
| Author: |
Lin, Stan C. Whipple, David M. Ho, Charles S. |
| Appeared in: |
Communications in statistics |
| Paging: | Volume 27 (1998) nr. 6 pages 1419-1432 |
| Year: |
1998 |
| Contents: |
In this article, the Food and Drug Administration's (FDA) medical device substantial equivalence provision will be briefly introduced and some statistical methods useful for evaluating device equivalence are discussed. A sample size formula is derived for limits of agreement, which may be used to assess statistical equivalence in certain medical device situations. Simulation findings on the formula are presented, which can be used to guide sample size selections in common practical situations. Examples of the sample size procedure are given. |
| Publisher: |
Taylor & Francis |
| Source file: |
Elektronische Wetenschappelijke Tijdschriften |
Details for article 9 of 21 found articles
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